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During the total study period, all hospitalization activities for all children who are participating in enhanced hospitalization tracking will be reported. Protocol amendment 4 information has been updated with protocol amendment 4's information: Around 20,000 children will be registered in the active surveillance program in the 6-12 weeks program to mirror RTS,S/AS01E in the 6-12 weeks age group, and 20,000 children in the 5-17 months group will be enrolled in the 5-17 months group to mimic RTS,S/AS01E in the 5-17 months age group, with similar procedures in the 5-17 months group. If a cerebrospinal fluid sample is taken as part of normal procedures, part of the sample will be stored. Rationale for Amendment 4: From a post-hoc review of Phase III's MALARIA-055's data regarding cerebral malaria, the background section has been updated with statistics about cerebral malaria from a post-hoc review. Indeed, home visits at 12 months and 24 months after the last RTS,S/AS01E dose, have helped to identify protocol-defined diseases that may have long-term window periods and that may not have been reported if the subject did not visit a health care facility, as well as monitor the presence of malaria episodes for testing vaccine effects. However, if the cases of malaria were found during an EPI-MAL-005 home visit, which coincides with a home visit planned in EPI-MAL-002, the activities will be chronicled in EPI-MAL-002. Rationale for Amendment 5: The study size was reduced from 40,000 to 30,000 children in active surveillance, with at least 20,000 children enrolled in areas where the RTS,S/AS01E vaccine will be introduced, in order to ensure synergy with the WHO pilot project. In Section 9. 3. 2 and the corresponding portion of Section 4 Abstract, the wording of the last two "study variables" (study endpoints) on "occurrence of hospitalisations" and "occurrence of death" has been changed. Section 9. 2. 5. 3 Meningitis has been updated, with the addition of a new opening paragraph, the addition of a "turbid macroscopic aspect" as a sign of CSF abnormality, and the clarification that clinically suspect meningitis cases included subjects with no CSF sample or no alternative diagnosis. In Tables 6-9. The estimated birth cohort of 17,250 people has increased since being shown in bullet 1 above with greater clarity on the estimated incidence of events after dose administration based on either: 15,000 subjects, 10,000 participants, the estimated birth cohort of 11,500 subjects, and an estimated birth cohort of 17,250 children. The study will not include changes in study staff on protocol cover page, but on the protocol cover page, note that the EPI-MAL-002 study sites in Burkina Faso will prematurely end the research and that sites in Malawi, one of the countries where RTS,S/AS01E will not be introduced through the MVIP will not take part in the study. Accordingly, the investigation EPI-MAL-002 in Burkina Faso's early terminations and details collected and recorded in those sites will be published in a descriptive manner. The RTS,S/AS01E vaccine will be available in 3 countries in order to align with the MVIP. Given that the RTS,S/AS01E vaccine rollout date in Malawi was planned in October 2018, the baseline results that may be collected in Malawi in the EPI-MAL-002 study would be too limited to be useful for the before/after comparisons in this region.
Source link: https://clinicaltrials.gov/ct2/show/NCT02374450
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